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Completed

NCT Number: NCT00636740

Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.

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Key information

Conditions

Hormone-Refractory Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

East Tallinn Central Hospital, Tallinn, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.

Exclusion criteria

  • Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)

Treatment and study plan

Zoledronic Acid 20mg Tablets

Drug

Oral enteric coated tablets, 20mg, weekly, 8 weeks

Other names: MER-101

Zoledronic acid

Drug

Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks

Other names: Zometa

Primary outcomes

  1. Effects on 4 markers of bone metabolism

    Time frame: Weekly

Secondary outcomes

  1. Brief Pain Inventory

    Time frame: Monthly

Sponsors and collaborators

Lead sponsor

Merrion Pharmaceuticals, LLC

Industry

Registry information

Official study title

A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 14, 2008
Registry last updated
Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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